藥物中的雜質(zhì)是否能被全面準(zhǔn)確地控制，直接關(guān)系到藥品的質(zhì)量可控與安全性。《中國藥典》多采用主成分自身對照法規(guī)定有關(guān)物質(zhì)的限度，而國外藥典中多用到雜質(zhì)對照品進(jìn)行檢測，這也就要求雜質(zhì)對照品符合一定的質(zhì)量標(biāo)準(zhǔn)后方可使用。對照品的標(biāo)定中常涉及的項目包括純度測定、結(jié)構(gòu)確證、含量測定等，考慮到雜質(zhì)對照品的微量性，標(biāo)定時選擇合適的分析方法十分重要，如進(jìn)行純度測定可使用高效液相色譜法、差示掃描量熱法等試樣用量少的分析儀器。

Whether the impurity in the drug can be fully comprehensive and accurately controlled, directly related to the quality of the drug safety and controllability. The principal component self-control method used in Chinese Pharmacopoeia to regulate material limit, and foreign methods used impurity reference, which requires the impurity reference substance to achieve a certain quality standard. Standard calibration usually includes purity determination, structure analysis, determination, and so on. Considering the impurity reference substance is traceful, so appropriate analysis method is very important. Less sample analysis instrument, such as high performance liquid chromatography, differential scanning calorimetry can be used for purity determination.

國家重大新藥創(chuàng)制項目（2009ZX09313-026）